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Case Status:    SETTLED
On or around 08/03/2022 (Date of order of final judgment)

Filing Date: June 03, 2015

According to the law firm press release, Puma Biotechnology, Inc. ("Puma" or the Company) is a development stage biopharmaceutical company, focusing on the acquisition, development, and commercialization of products to enhance cancer care. The Company’s lead product candidate is an investigational drug known as PB272 (“neratinib”), which the Company had touted as an extended adjuvant treatment of human epidermal growth factor receptor 2 (“HER2”)-positive metastatic breast cancer.

The Complaint alleges that throughout the Class Period, Defendants made false and/or misleading statements, and failed to disclose material adverse facts about the Company’s business, operations, prospects and performance. Specifically, during the Class Period, Defendants made false and/or misleading statements and/or failed to disclose that: (1) the Company’s NDA filing would be for a positive early stage breast cancer indication, instead of the previously announced metastatic breast cancer; (2) Puma would need to submit additional safety data from preclinical carcinogenicity studies with its NDA filing, which Puma did not have; (3) the additional required studies would necessarily push the timeline for filing the NDA into the first quarter of 2016; (4) the Company overstated results from its Phase III ExteNET Trial; and (5) as a result of the foregoing, Defendants lacked a reasonable basis for their positive statements about the Company and its outlook, including in its financial statements and about the ongoing ExteNET trial.

On August 31, 2015, the Court issued an Order appointing Lead Plaintiff and Counsel. Lead Plaintiff filed a consolidated Complaint on October 16. Defendants filed a Motion to Dismiss the consolidated Complaint on November 30. On September 30, 2016, the Court issued an Order denying Defendants' Motion to Dismiss.

An amended Complaint was filed on June 6, 2017. On December 8, the Court issued an Order granting the motion to certify a class in this action.

According to media reports, on February 4, 2019, a federal jury determined that Puma made misrepresentations in one of four contested statements about the results of a clinical trial involving a breast cancer treatment, awarding investors damages worth $4.50 per share. On September 9, the Court issued an Order granting an award of prejudgment interest.

On October 29, 2021, the parties notified the Court that they had reached a Settlement in principle. On December 1, the parties entered into a Stipulation and Agreement of Settlement. The Court granted preliminary approval of the Settlement on December 29. On August 3, 2022, the Court granted final approval of the Settlement, including an award of Attorneys’ Fees and Expenses, and entered Final Judgment.

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